Topical Capsaicin for Cyclical Vomiting

NCT03223350 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 10658
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting.

Conditions

Cyclical Vomiting

Outcome Measures

Primary Outcomes (1)

• Nausea Visual Analog Scale

  Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea

  30 minutes

Study Arms (2)

Capsaicin

EXPERIMENTAL

0.1% capsaicin cream, one application

Drug: Capsaicin 0.1% Cream

Placebo

PLACEBO COMPARATOR

Topical cream with no active drug

Drug: Placebos

Interventions

Capsaicin 0.1% Cream DRUG

Topical application

Capsaicin

Placebos DRUG

placebo cream

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• suspected cyclical vomiting syndrome / cannabinoid hyperemesis
• active severe nausea or vomiting in the emergency department

You may not qualify if:

• pregnant women, children \< 18 years, no prior history of similar symptoms, suspected surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours, abdominal pain alone (without nausea or vomiting)

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Familial cyclic vomiting syndrome

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Dr. Joseph Miller, associate research director
• Organization: Henry Ford Hospital

jmiller6@hfhs.org

313-916-5419

Study Officials

• Joseph Miller, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical appearing placebo cream used for control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: December 20, 2017
• Primary Completion: August 5, 2019
• Study Completion: August 5, 2019
• Last Updated: December 15, 2021
• Results First Posted: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)